EFFICACY AND SAFETY OF TENELIGLIPTIN AS ADD ON THERAPY TO CONVENTIONAL THERAPY IN INDIAN PATIENTS WITH TYPE 2 DIABETES MELLITUS
Objective: Teneligliptin is a novel, highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor. The objective of present study was to investigate the efficacy and safety of teneligliptin as add on therapy in patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled by conventional therapy (metformin/glimepiride) in India.
Methods: Clinical study protocol was approved by Institutional Ethics Committee. T2DM patients (male/female) whose glycated haemoglobin (HbA1C) >7% were randomized to receive following group treatments viz. treatment A. Metformin/glimepiride plus add on teneligliptin 20 mg and treatment B. Metformin / Glimepiride for 24 week. Predesigned case report form (CRF) was used to collect information from the prescribing physicians regarding the efficacy and safety of teneligliptin. Efficacy variables included change in plasma blood glucose (fasting and postprandial) and glycated haemoglobin (HbA1C) from baseline to week 24. Treatment-emergent adverse events (TEAEs) were assessed.
Results: A total 120 type 2 diabetes patients were analysed. Teneligliptin as add on therapy with metformin/glimepiride significantly reduced plasma glucose (HbA1c, fasting and postprandial) concentration as compared to conventional therapy.
Conclusion: Add on therapy with teneligliptin was found superior over conventional-therapy in reducing plasma glucose concentration (fasting and postprandial) and HbA1c levels significantly in patients with T2DM. Further, it was found effective and well tolerated throughout the study period in Indian patients with type 2 diabetes mellitus who are inadequately controlled with conventional therapy.
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